510(k) · Cleared

Cleared

Comfort EZ

K121632510(k) TraditionalCleared Aug 10, 201267-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Simple Diagnostics, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Aug 10, 2012 as substantially equivalent to K080904 (Feel Tech, 2008) and 2 other predicates after a 67-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.

Decided: Aug 10, 2012
Review: 67 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K973899 (1997). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK973899 Unifine PentipsOwen Mumford USA, Inc. · 1997
2 generations backK033575 One.Click NeedleB.Braun Medical, Inc. · 2004
1 generation backK080904 Feel-Fine Insulin Pen NeedleFeel Tech · 2008 · Recalled
This deviceK121632 Comfort EZSimple Diagnostics, Inc. · 2012
Descendant · cites it directly · 0 of its ownK160199 Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all

K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K973899	Unifine Pentips	Owen Mumford USA, Inc.	1997	—
−2	K033575	One.Click Needle	B.Braun Medical, Inc.	2004	—
−1	K080904	Feel-Fine Insulin Pen Needle	Feel Tech	2008	7
0 (this device)	K121632	Comfort EZ	Simple Diagnostics, Inc.	2012	—
+1	K160199	Advocate Insulin Pen Needles	Diabetic Supply of Suncoast, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K121632, 1997–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FMI device

#1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K080904	Feel-Fine Insulin Pen Needle Summary page 1 …ulation: 880.5570 Class of device: Class 11. 2. The legally marketed device to which we are claiming equivalence 1807.92(a)(3)I Feel Fine insulin pen needle K080904 (Comfort EZ is a relabeled version of this product) as well as K(100005 and K(051899 Becton Dickenson Pen Needles. 3. De…	Feel Tech	2008	7
*	K100005	BD Pen Needle Summary page 1 …evice to which we are claiming equivalence 1807.92(a)(3)I Feel Fine insulin pen needle K080904 (Comfort EZ is a relabeled version of this product) as well as K(100005 and K(051899 Becton Dickenson Pen Needles. 3. Description of device: The Pen Needle consists of a sterile cap, needle cap nee…	Becton, Dickinson and Co.	2010	—
*	K051899	BD Pen Needle Summary page 1 …h we are claiming equivalence 1807.92(a)(3)I Feel Fine insulin pen needle K080904 (Comfort EZ is a relabeled version of this product) as well as K(100005 and K(051899 Becton Dickenson Pen Needles. 3. Description of device: The Pen Needle consists of a sterile cap, needle cap needle hub,…	Becton, Dickinson & CO	2005	—

Also cleared against K080904: 7 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K160199	Advocate Insulin Pen Needles	Diabetic Supply of Suncoast, Inc.	2016	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K160199 (Diabetic Supply of Suncoast, Inc., 2016) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K080904.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	71	2	208
2008	10	85	4	177
2009	7	177	3	263
2010	15	119	79	249
2011	12	113	5	240
2012	17	107	1	215
2013	11	87	1	255
2014	14	155	3	287
2015	10	89	1	567
2016	20	217	0	941
2017	9	253	16	1,547
2018	20	176	0	2,398
2019	12	186	5	4,896
2020	11	263	3	4,245
2021	18	143	7	4,532
2022	23	189	0	4,885
2023	18	112	2	4,986
2024	3	90	1	4,053
2025	11	141	0	2,424
2026	12	119	1 (1)	—

What is it indicated for?

These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121632 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121632: Comfort EZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121632

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026